ISO 13485 Consultant
FSSC 22000 Consultant
I want to help you achieve ISO 13485 certification
My team of ISO 13485 consultants has everything you need to achieve ISO certification quickly and affordably. We have a 100% success rate and we guarantee our work. Schedule a free consultation to learn more.
"Keep it Simple. Keep it Real."
--- The ISO Consultant
"Everything you need!"
--- Amelia Manlutac, Cedars-Sinai Medical Center
"A full suite of services to ensure you have a smooth A to Z certification experience."
Custom Documentation
Custom documentation includes SOPs, SSOPs, forms, registers, checklists, and so forth. These custom procedures are necessary to pass an ISO 13485 certification audit successfully. Our ISO 13485 consultants spend days of elicitation and development to ensure that your documentation aligns perfectly with your actual best practices and with the ISO 13485 requirements.
Gap Assessment and Action Plan
Your path to compliance will be made possible through a gap assessment and a detailed action plan that will be provided by your ISO 13485 consultant. This action plan is the heart of the entire implementation project.
ISO 13485 Implementation
Implementing your ISO 13485 program is a major project. Your ISO 13485 consultant will use an online project management system to help manage the implementation from A to Z. The system ensures that all steps are completed, all requirements are met, and that you are ready to pass your audit with flying colors.
Custom Software Solutions
You will need a highly customizable and robust software solution to help you track the 200+ ISO 13485 requirements. We can provide you with our own turn-key software solution, or we can work with your own in-house solution to ensure that your ISO compliance and maintenance is manageable.
ISO 13485 Training
ISO 13485 training is provided to ensure that your whole team is competent in the ISO 13485 requirements and ready for the ISO certification audit. Training is available live as well as through our Learning Management System.
We help you implement ISO 13485 from A to Z. As part of your ISO 13485 implementation, your consultant will help you identify your environmental aspects, your environmental impacts, and assess the risks and opportunities in your organization that can lead to improved environmental performance. A life cycle perspective is applied to your products and services to ensure that all environmental impacts are identified.
Jared Clark JD MBA PMP
As an medical devices quality management systems consultant, I have helped over 200 clients achieve ISO 13485 certification quickly, easily, and affordably. I am a certified regulatory affairs professional, lead auditor, lean six sigma black belt, and project manager.
"Jared was always ready to help!"
-- Yoedvin Vasquez, President of Axcex
ISO 13485 is an international standard for developming an environmental management system for your organization. ISO has many other ISO management system standards, including the also popular ISO 45001 (Health and Safety) and ISO 9001 (Quality Management) standards. The ISO 9001 standard is the most popular ISO standard in the world.
A certification body is auditing company who will come and audit your ISO system and issue you the certificate if you pass.
The certification process can be confusing, but our ISO 13485 consultancy can help you get ISO 13485 certified quickly and efficiently. Our goal is to build a system that will make is easy to maintain and continually improve your quality management system.
Benefits of ISO 13485
Enhanced Company Image
The ISO 13485 mark on your marketing materials will greatly enhance your image and result in more customers.
Customer Satisfaction
The environmental management principles of ISO 13485 will greatly improve your customer satisfaction.
Reduced Costs
As you implement ISO 13485 you will enhance your ability to continually improve your systems and processes and increase efficiency. The PFDA cycle (Plan Do Check Act) is a process of continual improvement that is integrated right into the ISO 13485 standard.
Regulatory Compliance
Don't worry about meeting regulatory requirements as you excel in your continually improving environmental management system.
Our ISO 13485 consultancy can help you get ISO 13485 certified quickly and efficiently. Our goal is to build a system that will make is easy to maintain and continually improve your environmental management system.
© 2025 by the Certify Consulting Group